{"id":33042,"date":"2026-03-13T08:47:12","date_gmt":"2026-03-13T11:47:12","guid":{"rendered":"https:\/\/sobelconsult.com\/news-imdrf-publishes-regulatory-reliance-playbook\/"},"modified":"2026-10-24T06:39:58","modified_gmt":"2026-10-24T09:39:58","slug":"news-imdrf-publishes-regulatory-reliance-playbook","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/es\/news-imdrf-publishes-regulatory-reliance-playbook\/","title":{"rendered":"Noticias: El IMDRF publica el Libro de Jugadas de la Confianza Normativa"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">El entorno normativo de los productos sanitarios ha experimentado importantes ajustes en los distintos mercados. En medio de este escenario, cada vez se presta m\u00e1s atenci\u00f3n a los enfoques que permiten a las autoridades reguladoras confiar en las evaluaciones ya realizadas por autoridades de referencia de confianza, sin renunciar a la responsabilidad reguladora local, lo que se conoce como confianza reguladora. <\/p>\n\n<p class=\"wp-block-paragraph\">Las recientes acciones del IMDRF, la FDA, Anvisa y los reguladores asi\u00e1ticos demuestran que este enfoque est\u00e1 ganando terreno en los debates reguladores mundiales.<\/p>\n\n<p class=\"wp-block-paragraph\">En un sector en constante evoluci\u00f3n, seguir la pista de estas iniciativas es esencial para alinear las estrategias reguladoras, anticiparse a los impactos y reducir la incertidumbre.<\/p>\n\n<p class=\"wp-block-paragraph\">A continuaci\u00f3n se exponen las principales novedades normativas de las \u00faltimas semanas.<\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Consejo:<\/strong> Los suscritos a <a href=\"https:\/\/sobelconsult.com\/es\/?popup=810\"><em>Noticias Sobel<\/em><\/a>nuestro bolet\u00edn gratuito, ya saben todo esto, porque son los primeros en recibir la informaci\u00f3n. \u00a1Suscr\u00edbete y mantente a la vanguardia! <\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-imdrf-and-regulatory-reliance\">IMDRF y dependencia normativa<\/h2>\n\n<p class=\"wp-block-paragraph\">En primer lugar, es importante comprender el concepto de dependencia normativa.<\/p>\n\n<p class=\"wp-block-paragraph\">La confianza reguladora es la pr\u00e1ctica por la que una autoridad reguladora considera y utiliza, total o parcialmente, las evaluaciones realizadas por otras autoridades reguladoras de confianza, al tiempo que sigue manteniendo la responsabilidad de la decisi\u00f3n final dentro de su propia jurisdicci\u00f3n.<\/p>\n\n<p class=\"wp-block-paragraph\">Este enfoque pretende evitar la duplicaci\u00f3n de esfuerzos reguladores, promover un uso m\u00e1s eficiente de los recursos y acelerar los procesos de revisi\u00f3n, sin comprometer la seguridad, la eficacia o el rendimiento del producto.<\/p>\n\n<p class=\"wp-block-paragraph\">La dependencia reguladora puede adoptar distintas formas, como revisiones abreviadas, reconocimiento de decisiones reguladoras extranjeras o modelos de trabajo compartido entre autoridades.<\/p>\n\n<p class=\"wp-block-paragraph\">Aunque el concepto no es nuevo, su adopci\u00f3n ha cobrado impulso en los \u00faltimos a\u00f1os debido a la creciente complejidad tecnol\u00f3gica de los dispositivos m\u00e9dicos.<\/p>\n\n<p class=\"wp-block-paragraph\">Pero, \u00bfd\u00f3nde encaja la IMDRF en todo esto?<\/p>\n\n<p class=\"wp-block-paragraph\">A finales de febrero de 2026, el IMDRF (Foro Internacional de Reguladores de Dispositivos M\u00e9dicos) public\u00f3 el <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/2\/imdrf-publishes-regulatory-reliance-playbook-docum\"><em>Playbook for Medical Device Regulatory Reliance Programs (Manual para los programas de confianza reguladora de productos sanitarios)<\/em><\/a>.<\/p>\n\n<p class=\"wp-block-paragraph\">Este documento ofrece orientaciones pr\u00e1cticas a las autoridades reguladoras interesadas en desarrollar o mejorar programas formales de confianza reguladora para productos sanitarios y diagn\u00f3sticos in vitro.<\/p>\n\n<p class=\"wp-block-paragraph\">Desarrollado por el Grupo de Trabajo sobre Buenas Pr\u00e1cticas de Revisi\u00f3n Reglamentaria (GRRP), el libro de jugadas consolida las definiciones, presenta ejemplos de modelos existentes y esboza pasos pr\u00e1cticos para implantar programas basados en la confianza reglamentaria, reforzando al mismo tiempo de forma coherente la independencia reglamentaria y la responsabilidad en la toma de decisiones.<\/p>\n\n<p class=\"wp-block-paragraph\">Para los fabricantes, esto representa un cambio significativo en el panorama normativo, con posibles repercusiones en los plazos de aprobaci\u00f3n, las estrategias de presentaci\u00f3n y la priorizaci\u00f3n del mercado.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-updates-reinforcing-the-global-trend\">Las actualizaciones normativas refuerzan la tendencia mundial<\/h2>\n\n<p class=\"wp-block-paragraph\">Adem\u00e1s de la iniciativa IMDRF, otros acontecimientos recientes refuerzan la b\u00fasqueda de una mayor eficacia y previsibilidad reglamentarias.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-core-functions-and-priorities-at-the-fda\">Funciones b\u00e1sicas y prioridades de la FDA<\/h3>\n\n<p class=\"wp-block-paragraph\">En Estados Unidos, la <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/3\/fda-official-core-inspectional-functions,-prioriti\">FDA confirm\u00f3 que las funciones b\u00e1sicas y las prioridades de su programa de inspecci\u00f3n<\/a> permanecen inalteradas, a pesar de los recientes cambios de liderazgo.<\/p>\n\n<p class=\"wp-block-paragraph\">La agencia seguir\u00e1 centr\u00e1ndose en las inspecciones basadas en el riesgo, las inspecciones previas a la homologaci\u00f3n y las actividades de vigilancia, incluidas las inspecciones en instalaciones internacionales.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"684\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-1024x684.jpg\" alt=\"Una profesional est&#xE1; trabajando en unos documentos sobre un escritorio. Los documentos est&#xE1;n en un portapapeles, donde unas manos femeninas sostienen un bol&#xED;grafo, como si estuvieran analizando la informaci&#xF3;n. Al fondo, se ve material de oficina y una bandera estadounidense.  \" class=\"wp-image-25556\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-1024x684.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-768x513.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration.jpg 1294w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\">Esta posici\u00f3n refuerza la importancia de <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/medical-device-quality-consulting\/\">unos sistemas de calidad s\u00f3lidos<\/a> y una postura de cumplimiento continuo para las empresas que operan en el mercado.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-udi-system-goes-live-in-brazil\">El sistema UDI entra en funcionamiento en Brasil<\/h3>\n\n<p class=\"wp-block-paragraph\">En Brasil, <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/entra-em-operacao-sistema-que-traz-mais-seguranca-para-dispositivos-medicos-no-brasil\">Anvisa ha lanzado el Sistema \u00danico de Identificaci\u00f3n de Dispositivos M\u00e9dicos (Siud)<\/a>, alineado con las directrices del IMDRF.<\/p>\n\n<p class=\"wp-block-paragraph\">La iniciativa refuerza la trazabilidad y la vigilancia posterior a la comercializaci\u00f3n, acercando al pa\u00eds a las pr\u00e1cticas normativas adoptadas internacionalmente y aumentando la transparencia en toda la cadena de suministro.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-malaysia-updates-rules-for-medical-device-purchases\">Malasia actualiza las normas para la compra de productos sanitarios<\/h3>\n\n<p class=\"wp-block-paragraph\">En Asia, la autoridad reguladora de Malasia public\u00f3 <a href=\"https:\/\/cisema.com\/en\/malaysia-medical-device-procurement\/\">nuevas normas que rigen la adquisici\u00f3n de productos sanitarios<\/a> por hospitales e instituciones sanitarias.<\/p>\n\n<p class=\"wp-block-paragraph\">La normativa aclara que los proveedores que participen en procesos de compra p\u00fablicos o privados deben cumplir plenamente los requisitos normativos locales, incluida la concesi\u00f3n de licencias adecuadas, lo que refuerza el papel de la normativa en las actividades de comercializaci\u00f3n.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-monitoring-as-a-competitive-advantage\">El control normativo como ventaja competitiva<\/h2>\n\n<p class=\"wp-block-paragraph\">Las recientes iniciativas del IMDRF, la FDA, Anvisa y las autoridades reguladoras asi\u00e1ticas demuestran claramente que el entorno regulador mundial est\u00e1 en constante transformaci\u00f3n.<br\/>Para las empresas de productos sanitarios, el seguimiento de estos cambios no debe considerarse \u00fanicamente una obligaci\u00f3n de cumplimiento, sino una herramienta estrat\u00e9gica.<\/p>\n\n<p class=\"wp-block-paragraph\">Comprender c\u00f3mo se est\u00e1n incorporando a los marcos normativos conceptos como la dependencia normativa puede ayudar a las empresas a anticiparse a los escenarios, reducir los riesgos, optimizar las inversiones y tomar decisiones m\u00e1s informadas sobre la expansi\u00f3n internacional.<\/p>\n\n<p class=\"wp-block-paragraph\">Por eso, mantenerte informado sobre estos avances puede marcar la diferencia en tu pr\u00f3xima estrategia reguladora.<\/p>\n\n<p class=\"wp-block-paragraph\">Y recuerda: \u00a1el <a href=\"https:\/\/sobelconsult.com\/es\/#footer-cta\/\">equipo de Sobel est\u00e1 a tu disposici\u00f3n para guiarte<\/a> a trav\u00e9s de los viajes normativos globales!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Comprende el concepto de dependencia normativa y c\u00f3mo las iniciativas de la IMDRF, la FDA y la Anvisa est\u00e1n influyendo en la normativa mundial.<\/p>\n","protected":false},"author":12,"featured_media":33041,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"page_builder":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"categories":[140],"tags":[546],"market":[514],"content_type":[518],"class_list":["post-33042","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-productos-sanitarios","tag-registro-y-acceso-al-mercado-es","market-global-es","content_type-noticias-es"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - 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